Duns Number:020198912
Device Description: Merit Medical Pressure Infusor Bag, 500 mL
Catalog Number
PIB500
Brand Name
N/A
Version/Model Number
PIB500
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
Yes
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
KZD
Product Code Name
INFUSOR, PRESSURE, FOR I.V. BAGS
Public Device Record Key
483e2032-7253-48f7-92ac-05e39699780e
Public Version Date
April 28, 2022
Public Version Number
3
DI Record Publish Date
October 21, 2019
Package DI Number
57613327500177
Quantity per Package
12
Contains DI Package
07613327500172
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
case
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 304 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1702 |
| U | Unclassified | 12 |